Jithuraj Dharmaraj

QC Molecular Biology:

• Identify analysis of Biosimilars Drug substance and Drug product by reducing and non_reducing SDS-PAGE using Silver staining and Coommassie Staining methods.
• Identification and Estimation of impurities by NATIVE PAGE for Biosimilars.
• Identification of Mycoplasma by PCR technique.
• Quantification of Protein A leachate and HCP in Biosimilar Drug substance and Drug product by ELISA techniques.

QC BIOASSAY:

• Assessment of Relative potency of Aflibercept DS and DP by VEGF bioassay.
• Assessment of Relative potency of Adalimumab DS and DP by TNF-alpha neutralization assay using apoptosis method.
• Maintenance of U937&L929 cell lines.

QC Immunoanalytical lab:

• Quantification of Streptococcus pneumonia serotype specific IgG levels in Human sera by ELISA.
• Characterization and Establishment of Quality control sera.
• Maintenance of ELISA documents electronically through software(21CFR part 11).
• Quantification of opsonic Index for antibodies against S.pneumonia by MOPA.
• Handling of Human Leukemia 60 cell lines (Revival,Propagation and differentiation).
• Counting of HL60 cells for differentiation and assay by using Haemocytometer.

QC Microbiology:

• Environmental monitoring.
• Microbial analysis of water.
• Bacterial Endotoxin test.
• Testing of Biological Indicators.
• Amenable for Growth promotion test.